Lopinavir/Ritonavir Mylan

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Lopinavir 100mg; Ritonavir 25mg;  

متاح من:

Viatris Limited

INN (الاسم الدولي):

Lopinavir 100 mg

جرعة:

100mg/25mg

الشكل الصيدلاني:

Film coated tablet

تركيب:

Active: Lopinavir 100mg Ritonavir 25mg   Excipient: Colloidal silicon dioxide Copovidone Opadry white 20C580015 Sodium stearyl fumarate Sorbitan laurate

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Mylan Laboratories Limited

الخصائص العلاجية:

Lopinavir/Ritonavir Mylan is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.

ملخص المنتج:

Package - Contents - Shelf Life: Blister pack, Cold form blister OPA/Al/PVC with hard tempered Aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Cold form blister OPA/Al/PVC with hard tempered Aluminium foil - 120 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE bottle with PP screw cap and aluminium induction sealing liner wad - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE bottle with PP screw cap and aluminium induction sealing liner wad - 120 tablets - 36 months from date of manufacture stored at or below 25°C

تاريخ الترخيص:

2015-01-08

نشرة المعلومات

Page 1 of 5
INEW ZEALAND CONSUMER MEDICINE INFORMATION
LOPINAVIR/RITONAVIR MYLAN
_LOPINAVIR/RITONAVIR FILM COATED TABLET 100/25MG, 200/50MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
Lopinavir/Ritonavir Mylan.
This leaflet answers some common
questions about Lopinavir/Ritonavir
Mylan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Lopinavir/Ritonavir Mylan against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT
LOPINAVIR/RITONAVIR
MYLAN IS USED FOR
Lopinavir/Ritonavir Mylan is used to
treat

HIV-1 infection, in combination
with other antiretroviral agents in
adults and children aged 2 years
and older
Lopinavir/Ritonavir Mylan contains
the active ingredients lopinavir and
ritonavir. It belongs to a group of
medicines called protease
inhibitors.
It works by producing an immature,
non-infectious virus and slows down
the spread of the infection in your
body.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
LOPINAVIR/RITONAVIR
MYLAN
_WHEN YOU MUST NOT TAKE_
_IT_
DO NOT TAKE LOPINAVIR/RITONAVIR
MYLAN IF YOU HAVE AN ALLERGY TO:

any medicine containing
lopinavir or ritonavir.

any of the ingredients listed
at the end of this leaflet.

Some of the symptoms of
an allergic reaction may
include: shortness of
breath; wheezing or
difficulty breathing; swelling
of the face, lips, tongue or
other parts of the body;
rash, itching or hives on the
skin.
DO NOT TAKE LOPINAVIR/RITONAVIR
MYLAN IF YOU HAVE SEVERE LIVER
PROBLEMS.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may aff

خصائص المنتج

NEW ZEALAND DATA SHEET
LOPINAVIR/RITONAVIR MYLAN
1. PRODUCT NAME
Lopinavir/Ritonavir Mylan, 100mg/25mg & 200mg/50mg, film coated
tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 100mg/25mg or 200mg/50mg of
lopinavir/ritonavir.
3. PHARMACEUTICAL FORM
100 mg/25 mg: White, film coated, ovaloid, biconvex bevelled edge
tablet debossed with ‘MLR4’ on one
side of the tablet and plain on the other side.
200 mg/50 mg: White, film coated, ovaloid, biconvex bevelled edge
tablet debossed with ‘MLR3’ on one
side of the tablet and plain on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Lopinavir/Ritonavir Mylan is indicated for the treatment of HIV-1
infection, in combination with other
antiretroviral agents in adults and children aged 2 years and older.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
DOSE
ADULTS
The recommended dosage of Lopinavir/Ritonavir Mylan tablets is 400/100
mg (two 200/50 mg tablets)
twice daily. Lopinavir/Ritonavir Mylan tablets may also be
administered as 800/200 mg (four 200/50 mg
tablets) once daily, in patients with less than three
lopinavir-associated mutations. There are insufficient
data to support the use of once daily administration of
Lopinavir/Ritonavir Mylan for adult patients with
three or more lopinavir-associated mutations (see section 5.1).
_CONCOMITANT THERAPY: EFAVIRENZ, NEVIRAPINE, AMPRENAVIR OR NELFINAVIR
_
A dose increase of lopinavir/ritonavir to 500/125 mg twice daily (such
as two 200/50 mg tablets and one
100/25 mg tablet) should be considered when used in combination with
efavirenz, nevirapine, amprenavir
or nelfinavir in treatment experienced patients where reduced
susceptibility to lopinavir is clinically
suspected (by treatment history or laboratory evidence) (see section
4.5).
PAEDIATRIC PATIENTS
The adult dose of Lopinavir/Ritonavir Mylan tablets (400/100 mg twice
daily) may be used in children 35 kg
or greater. For children weighing less than 35 kg and ABLE TO SWALLOW
TABLETS, refer to the dosing guideli